NCT05109988

Brief Summary

The World Health Organization advocates for breastfeeding as the best source of food for optimal infant development, which reduces the risk of infant mortality and morbidity. The objectives of this study are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding. The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. We expect that women who receive the intervention will have a higher rate and longer duration of exclusive breastfeeding, fewer depressive symptoms and better parent-child relationship. The knowledge gained from this study can provide direction for the development of flexible, accessible and culturally sensitive interventions to promote breastfeeding and mental health in Chinese society.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
649

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

3.3 years

First QC Date

October 17, 2021

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of exclusive breastfeeding

    The prevalence/proportion of infants younger than 1 month who are exclusively breastfed is calculated as the number of infants younger than 1 month who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 1 month.

    1 month

Secondary Outcomes (11)

  • Prevalence of exclusive breastfeeding

    2 months

  • Prevalence of exclusive breastfeeding

    4 months

  • Prevalence of exclusive breastfeeding

    6 months

  • Duration of exclusive breastfeeding

    1 month

  • Duration of exclusive breastfeeding

    2 months

  • +6 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.

Behavioral: Breastfeeding telephone support

Control

NO INTERVENTION

Standard postpartum care

Interventions

The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or above;
  • giving birth to a single healthy baby at term
  • ability to speak and read the Chinese language

You may not qualify if:

  • psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ngai Fei Wan

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Fei Wan Ngai, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome measures will be collected by a research assistant who is blind to the group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 17, 2021

First Posted

November 5, 2021

Study Start

April 18, 2022

Primary Completion

July 28, 2025

Study Completion

July 28, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations